CFR – Code of Federal Regulations Title 21
//www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=820
MDUFA
Medical Device User Fee Amendments (MDUFA).
See the fees for Fiscal year 2020.
//www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa
FDA Medical Device Reporting Regulation
//www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=803
FDA Unique Device Identification System (UDI)
//www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system
Electronic Records, Electronic Signatures – Part 11
//www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11
Medical Device Labeling – Part 801
//www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=801
Medical Devices & Cybersecurity
//www.fda.gov/medical-devices/digital-health/cybersecurity
Medical Device Establishment Registration & Listing
//www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing